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FDA 510(k) Application Details - K151458
Device Classification Name
Orthosis, Spinal Pedicle Fixation
More FDA Info for this Device
510(K) Number
K151458
Device Name
Orthosis, Spinal Pedicle Fixation
Applicant
Double Medical Technology Inc
No. 18 Shanbianhong East Road, Haicang District
XIAMEN 361022 CN
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Contact
DA ZENG
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNI
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More FDA Info for this Product Code
Date Received
06/01/2015
Decision Date
08/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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